Innovation & Business Idea
TolerogenixX has a patented technology that can be used to suppress unwanted immune responses in the body. This novel cell therapy will revolutionize the treatment of transplant recipients and numerous autoimmune diseases. The unique feature of the TolerogenixX technology is the safe and reliable suppression of an (unwanted) immune response against a donor organ (transplantation) or self-antigens (autoimmune diseases) without suppression of (wanted) immune responses against third party antigens such as bacteria or viruses. This tailored immunosuppressive therapy is achieved by the production of tolerogenic MIC cells through incubation of specific white blood cells (“PBMCs“) with the anti-proliferative substance Mitomycin C. The TolerogenixX therapy will be supplied in a “kit” that can then be used in any hospital throughout the world. The “kit” will be manufactured in a standard form for the individual indications. The individual component derives from the extracted blood cells (“PBMCs”) of the patients.
Customers / Target Market
The therapy kit can be shipped to customers (hospitals) easily in direct sales. Unlike conventional pharmacotherapy, the TolerogenixX method offers a new therapeutic approach. To date, there are no innovative competitors in this field. In the world, approximately 150,000 patients have transplant surgery every year and millions of people suffer from autoimmune disease (e.g. 5 M patients with SLE).The potential market is worth at least €30 B. So far, no individualized therapies are available for the different indications.
The “main competitor” to the TolerogenixX method is conventional immunosuppression. The disadvantages of this therapy are insufficient prophylaxis of rejection, particularly chronic rejection, and multiple side-effects. Induction of haematopoietic chimaerism through allogenic donor stem cell transplantation following intensive conditioning of the recipient (incl. radiation). Although these procedures achieve donor-specific immunosuppression or tolerance in some cases, they are associated with extensive side effects, significant logistical hurdles and high costs.
Intellectual Property Status
Patents filed in Europe [EP 2318020] and the US [US 13/001,729].
Development Status & Future Steps
TolerogenixX has successfully tested its innovative therapeutic kit for the manufacture of a customized immunosuppression in kidney transplantation in a phase I study (TOL-1). Phase I results were promising and so we are preparing for a TOL-2 phase 2 study. In a multicenter study starting from Q3 2018 we will test the MIC cell therapy together with reduced immunosuppression compared to standard of care in 10 kidney transplant centers in approximately 120 patients. We are also investigating the TolerogenixX method in further preclinical models of systemic lupus erythematosus and rheumatoid arthritis.
It is likely to be possible to earn revenue from the sale of the therapy kits from 2021 onwards. There will be several exit options, e.g. at the end of the phase II trial (proof of concept) or after the therapy kit has been approved for clinical use.
PD Dr. M. Schaier (CEO) is MBA, scientist (Autoimmun) and medical doctor. Prof. Dr. C. Morath (CSO) is an internationally recognized expert in the field of organ transplantation. PD Dr. A. Schmitt (CTO) is consultant in transfusion medicine and expert on GMP manufacturing.
TolerogenixX plans to close a Series A financing of approximately €12 M with several potential investors.
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